Harvard’s patented OncoMouse has been a bestseller for cancer research here in the US. Two Harvard researchers took an available laboratory mouse and inserted a heritable cancer-causing gene into the creature’s DNA. In the US, Harvard owns three patents covering aspects of the mouse and its creation that are exclusively licensed to Du Pont. U.S. Patent Nos. 4,736,866, 5,087,571, and 5,925,803. The patents were filed pre-1995 and thus have a term that lasts for 17 years from the patent issuance. The first two 17-year terms have expired, but the third could last until 2016 – except for the terminal disclaimer discussed below.

In 2010, an anonymous third party requestor (TPR) filed a reexamination request for the ‘803 patent. Last June, the USPTO confirmed the patentability of the challenged claims. However, the USPTO agreed with the TPR that a broadly worded terminal disclaimer filed in the parent ‘571 application meant that the’803 patent also expired in 2005. Thus, it doesn’t matter whether the claims are valid over the prior art because they are expired. Because the patent had expired, the USPTO refused to allow Harvard to add additional claims to the patent during reexamination.

In the terminal disclaimer filed in the parent case, the patentee agreed to disclaim the term of the parent patent as well as any patent claiming benefit of the patent under 35 U.S.C. §120. Since the ‘803 patent claims priority to the parent under §120, that disclaimer seems to be effective to limit the ‘803’s term as well. However, the disclaimer was never particularly filed in the ‘803 case (only its parent). Further, nothing in the record indicates that the examiner acknowledged receipt of the disclaimer in the parent case and there is no evidence that the terminal disclaimer fee was actually paid. The examiner did, however, remove the double patenting rejection had been blocking the issuance of the parent case and the filed terminal disclaimer authorized payment of the fee.

In the reexamination, the USPTO gave full support the examiner’s decision that the terminal disclaimer limited the ‘803 patent term – finding that Harvard could have corrected the problems with the filing back when the patents were pending but that it is too late now.

It is only now that the non-standard disclaimer language of the terminal disclaimer filed in 1989 has an effect … [that] the patent owner [is] attempting to argue that ther terminal disclaimer had no legal effect. . . . [B]ecaues patent owner did not timely seek withdrawal of the terminal disclaimer from the parent patent as per the procedures in MPEP [at the time], patent owner cannot seek now to nullify the effect of the terminal disclaimer after the issued patent has reached its expiry date.

In response, Harvard has now filed a civil action in the Eastern District of Virginia asking the court to overturn the USPTO decision. For now, however, it appears that the mice are finally free although their title (OncoMouse) is still a registered trademark owned by DuPont.

The reason one cannot use a reissue to fix a terminal disclaimer problem so that the patent does not prematurely expire is that one cannot even file a reissue application with respect to an expired patent?

Perhaps congress could, in the interests of justice, simply extent the patent term.